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DiviTum-TKa Assay for Breast Cancer

N/A

Recruiting

Led By Mariya Rozenblit

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically confirmed metastatic ER-positive (> 10%), PR-positive or PR-negative, and HER2-negative (0 by immunohistochemistry [IHC] or if +1 or +2 by IHC, not amplified by fluorescence in situ hybridization [FISH]) breast cancer as per the 2018 joint American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines

Participants must be starting CDK4/6 inhibitor and endocrine therapy as part of first-line therapy per standard of care and be previously CDK4/6 inhibitor-naïve

Must not have

Participants without evidence of metastatic disease prior to registration

Participants with prior use of CDK4/6 inhibitor therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method called DiviTum to see if it can help determine the right levels of medications for breast cancer patients. The trial will focus on patients with a specific type of breast

Who is the study for?

This trial is for individuals with ER/PR positive, HER2-negative metastatic breast cancer who are currently receiving CDK 4/6 inhibitors. It aims to optimize medication levels using the DiviTum-TKa test, which measures a biomarker associated with cell growth.

What is being tested?

The study tests if the DiviTum-TKa assay can help find the best dose of CDK 4/6 inhibitor medications and improve treatment by monitoring drug interactions and patient compliance in those undergoing first-line therapy for metastatic hormone-positive breast cancer.

What are the potential side effects?

Since this trial focuses on optimizing medication dosage through testing rather than introducing new drugs, side effects may be more related to adjustments in current treatments or potential issues from drug-drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is ER-positive, may be PR-positive or negative, and is not HER2-positive.

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I am starting CDK4/6 inhibitor and hormone therapy for the first time.

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I have not started CDK4/6 inhibitor therapy yet.

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I am 18 years old or older.

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I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has not spread to other parts of my body.

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I have previously used CDK4/6 inhibitor therapy.

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I am unable to give informed consent for the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with thymidine kinase activity (TKa) values that switch from profile 3 to profile 1 or 2 after medication compliance and drug-drug interaction assessment

Rate of improvement in CDK4/6 inhibitor response (i.e. moving from profile 3 to profiles 1 or 2)

Secondary study objectives

CDK4/6 inhibitor response via TKa levels upon CDK4/6 inhibitor dose reductions or changes in CDK4/6 inhibitor regimen due to adverse events

Clinical benefit rate (CBR) in patients with sub-optimal (profile 3) and optimal (profiles 1 and 2) CDK4/6 inhibitor response

Comparison of CDK4/6 inhibitor response profiles across the three CDK 4/6 inhibitors

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Health services research (DiviTum-TKa)Experimental Treatment1 Intervention

Patients undergo collection of blood samples per SOC on days 1, 15, and 28 of cycle 1, days 15 and 28 of cycle 2, days 15 and 28 of cycle 3, and day 28 of subsequent cycles for up to 12 cycles for analysis by DiviTum-TKa in the absence of disease progression or unacceptable toxicity.

0 / 8Eligibility criteria met